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Safety and Efficacy Study in Acute Ischaemic Stroke (VASST)

Primary Purpose

Stroke

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
V10153
Sponsored by
Vernalis (R&D) Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Acute, Ischaemic, Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Summary of Inclusion Criteria: Onset of new neurological signs of stroke within 3 to 9 hours of the time to initiation of treatment Aged 18 and above Provide consent Cerebral CT scan to show findings of early ischaemic changes consistent with the clinical diagnosis and an ASPECT score of between 5 and 10 inclusive. NIHSS score greater than 5 or less than or equal to 20. Summary of Exclusion Criteria: Coma Stroke with unknown time of onset Minor stroke symptoms and sings (<6 points on the NIHSS) which are rapidly improving by the time of randomisation. Major stroke symptoms and signs (>20 on the NIHSS) History of stroke in previous 6 weeks History of brain tumours CT scan results in an ASPECT score of <5 Haemorrhagic risk Abnormal laboratory values Positive urine pregnancy test, lactation or parturition within previous 30 days. Weight >135 kg Uncontrolled hypertension. Raised blood glucose History of or current serious illness Participation in another clinical trial within 4 weeks of drug administration -

Sites / Locations

  • Stroke Centre, Mayo Clinic
  • UCLA Stroke Network
  • Neurology Medical Group of Diablo Valley
  • Bethesda Memorial Hospital
  • Bradenton Research Centre
  • Ocala Neurodiagnostic Centre
  • Florida Hospital of Neuroscience Institute
  • Tallahassee Memorial Hospital
  • Florida Neurovascular Institue Stroke Center
  • Vascular Neurology, Loyola University Medical Center
  • Center for Advanced Medicine, Jewish Hospital
  • University of Louisville Hospital
  • UMAS Memorial Medical Centre
  • Sunrise Hospital and Medical Centre
  • Washoe Stroke Center
  • Stroke Centre, Neurological Institute, Carolinas Medical Centre
  • Forsyth Medical Center
  • Lancaster General Hospital
  • University of Pennsylvania Medical Center
  • Medical University South Carolina Hospitals and Clinics
  • Erlanger Health System
  • Neurological Institute, The Methodist Hospital
  • Division of Neuro-Ophthalmology, Virginia Commonwealth University
  • Gordon & Leslie Diamond Health Care Centre
  • Centre for Stroke Research, Vancouver Island Health Research Centre
  • 71 King Street West
  • Royal University Hospital
  • Hospital Charles LeMoyne

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

V10153, 1.0 mg/kg

V10153, 2.5 mg/kg

V10153, 5.0 mg/kg

V10153, 7.5 mg/kg

V10153, 10 mg/kg

Arm Description

Single acute intravenous bolus dose

Single acute intravenous bolus dose

Single acute intravenous bolus dose

Single acute intravenous bolus dose

Single acute intravenous bolus dose

Outcomes

Primary Outcome Measures

To establish the safety of five dose levels (1.0, 2.5, 5, 7.5 and 10 mg/kg)of V10153 in patients with acute ischaemic stroke.

Secondary Outcome Measures

To compare recanalisation rates across dose levels.
To compare clinical outcome between treatments by NIHSS, Modified Rankin Scale and Barthel Index.

Full Information

First Posted
September 1, 2005
Last Updated
May 4, 2016
Sponsor
Vernalis (R&D) Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT00144014
Brief Title
Safety and Efficacy Study in Acute Ischaemic Stroke
Acronym
VASST
Official Title
A Phase II, Multi-centre, Two-part Study to Evaluate the Safety and Efficacy of Study Drug in Acute Ischaemic Stroke.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
August 2005 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
March 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vernalis (R&D) Ltd

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A Phase II study to evaluate the safety and efficacy of five dose levels of study drug in acute ischaemic stroke
Detailed Description
An open label, dose escalation study where patients with acute ischaemic stroke will receive a single intravenous dose of study drug. There will be five dose levels with groups of 10 patients in each. Escalation to higher doses will occur following review of safety data from the previous dose.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Acute, Ischaemic, Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
V10153, 1.0 mg/kg
Arm Type
Experimental
Arm Description
Single acute intravenous bolus dose
Arm Title
V10153, 2.5 mg/kg
Arm Type
Experimental
Arm Description
Single acute intravenous bolus dose
Arm Title
V10153, 5.0 mg/kg
Arm Type
Experimental
Arm Description
Single acute intravenous bolus dose
Arm Title
V10153, 7.5 mg/kg
Arm Type
Experimental
Arm Description
Single acute intravenous bolus dose
Arm Title
V10153, 10 mg/kg
Arm Type
Experimental
Arm Description
Single acute intravenous bolus dose
Intervention Type
Drug
Intervention Name(s)
V10153
Other Intervention Name(s)
Code Names: V10153, BB-10153, CAS Registry Number: 931101-84-7, Proposed INN: Troplasminogen alfa
Intervention Description
Single acute intravenous bolus dose up to 10 mg/kg
Primary Outcome Measure Information:
Title
To establish the safety of five dose levels (1.0, 2.5, 5, 7.5 and 10 mg/kg)of V10153 in patients with acute ischaemic stroke.
Time Frame
Ongoing
Secondary Outcome Measure Information:
Title
To compare recanalisation rates across dose levels.
Time Frame
Ongoing
Title
To compare clinical outcome between treatments by NIHSS, Modified Rankin Scale and Barthel Index.
Time Frame
Post-study completion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Summary of Inclusion Criteria: Onset of new neurological signs of stroke within 3 to 9 hours of the time to initiation of treatment Aged 18 and above Provide consent Cerebral CT scan to show findings of early ischaemic changes consistent with the clinical diagnosis and an ASPECT score of between 5 and 10 inclusive. NIHSS score greater than 5 or less than or equal to 20. Summary of Exclusion Criteria: Coma Stroke with unknown time of onset Minor stroke symptoms and sings (<6 points on the NIHSS) which are rapidly improving by the time of randomisation. Major stroke symptoms and signs (>20 on the NIHSS) History of stroke in previous 6 weeks History of brain tumours CT scan results in an ASPECT score of <5 Haemorrhagic risk Abnormal laboratory values Positive urine pregnancy test, lactation or parturition within previous 30 days. Weight >135 kg Uncontrolled hypertension. Raised blood glucose History of or current serious illness Participation in another clinical trial within 4 weeks of drug administration -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Hill
Organizational Affiliation
Foothills Hosptial
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stroke Centre, Mayo Clinic
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Facility Name
UCLA Stroke Network
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States
Facility Name
Neurology Medical Group of Diablo Valley
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Bethesda Memorial Hospital
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33435
Country
United States
Facility Name
Bradenton Research Centre
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34205
Country
United States
Facility Name
Ocala Neurodiagnostic Centre
City
Ocala
State/Province
Florida
ZIP/Postal Code
34470
Country
United States
Facility Name
Florida Hospital of Neuroscience Institute
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
Tallahassee Memorial Hospital
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
Florida Neurovascular Institue Stroke Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Vascular Neurology, Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Center for Advanced Medicine, Jewish Hospital
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
University of Louisville Hospital
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
UMAS Memorial Medical Centre
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
Sunrise Hospital and Medical Centre
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Facility Name
Washoe Stroke Center
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
Facility Name
Stroke Centre, Neurological Institute, Carolinas Medical Centre
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
Forsyth Medical Center
City
Winston Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Lancaster General Hospital
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17602
Country
United States
Facility Name
University of Pennsylvania Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Medical University South Carolina Hospitals and Clinics
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Erlanger Health System
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
Neurological Institute, The Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Division of Neuro-Ophthalmology, Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298-0599
Country
United States
Facility Name
Gordon & Leslie Diamond Health Care Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Name
Centre for Stroke Research, Vancouver Island Health Research Centre
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8R 1J8
Country
Canada
Facility Name
71 King Street West
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L5B 4A2
Country
Canada
Facility Name
Royal University Hospital
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7K 0L4
Country
Canada
Facility Name
Hospital Charles LeMoyne
City
Quebec
ZIP/Postal Code
J4V 2H1
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Safety and Efficacy Study in Acute Ischaemic Stroke

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